Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT05140304
Status:
UNKNOWN
Last Update Posted:
2021-12-01
First Post:
2021-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of FAZ in Diabetic Retinopathy Using OCT Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-17', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean area of FAZ in various stages of diabetic retinopathy and difference between these groups in superficial and deep capillary plexuses', 'timeFrame': 'baseline', 'description': 'analysis of foveal avascular zone in different stages of diabetic retinopathy using OCT angiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '23918361', 'type': 'RESULT', 'citation': 'Kim DY, Fingler J, Zawadzki RJ, Park SS, Morse LS, Schwartz DM, Fraser SE, Werner JS. Optical imaging of the chorioretinal vasculature in the living human eye. Proc Natl Acad Sci U S A. 2013 Aug 27;110(35):14354-9. doi: 10.1073/pnas.1307315110. Epub 2013 Aug 5.'}, {'pmid': '24349078', 'type': 'RESULT', 'citation': 'Choi W, Mohler KJ, Potsaid B, Lu CD, Liu JJ, Jayaraman V, Cable AE, Duker JS, Huber R, Fujimoto JG. Choriocapillaris and choroidal microvasculature imaging with ultrahigh speed OCT angiography. PLoS One. 2013 Dec 11;8(12):e81499. doi: 10.1371/journal.pone.0081499. eCollection 2013.'}, {'pmid': '13729802', 'type': 'RESULT', 'citation': 'NOVOTNY HR, ALVIS DL. A method of photographing fluorescence in circulating blood in the human retina. Circulation. 1961 Jul;24:82-6. doi: 10.1161/01.cir.24.1.82. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Study and assessment of characteristic changes in foveal avascular zone during different stages of diabetic retinopathy using OCTA.', 'detailedDescription': 'OCTA is superior to other retinal imaging techniques like fluorescein angiography(FA) as it does not require dye injection, Intravenous dye injection is time consuming and can have adverse side effects. Furthermore, the edges of the capillaries can become blurred due to dye leakage and imaging of the retina can only be 2D when using FA.\n\nOCTA provides both structural and functional (i.e. blood flow) information in tandem. The "corresponding" OCT b-scans can be co-registered with the simultaneous OCT angiograms so the operator is able to scroll through the OCT angiogram like a cube scan. As a result, the precise location of pathology can be viewed on the corresponding OCT b-scans. This makes OCTA a better tool when detecting the exact location of a retinal pathology.\n\nIn diabetic retinopathy OCTA can show choriocapillaris abnormalities and/or retinal microvascular abnormalities such as microaneurysms, vascular remodeling adjacent to the foveal avascular zone (FAZ), enlarged FAZ, and capillary tortuosity and dilation through different stages. OCTA can show smaller vascular changes not detectable by FA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients suffering from different stages of diabetic retinopathy.\n\nExclusion Criteria:\n\n* Other ocular problems affecting vision including glaucoma, cataract, amblyopia, hypertensive retinopathy, vein occlusion and uveitis.'}, 'identificationModule': {'nctId': 'NCT05140304', 'briefTitle': 'Analysis of FAZ in Diabetic Retinopathy Using OCT Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Quantitative and Qualitative Analysis of Foveal Avascular Zone Characteristics in Different Stages of Diabetic Retinopathy Using Optical Coherence Tomography Angiography (OCT-A)', 'orgStudyIdInfo': {'id': 'OCT angiography'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'interventionNames': ['Device: OCT angiography']}], 'interventions': [{'name': 'OCT angiography', 'type': 'DEVICE', 'description': 'OCT angiography of foveal avascular zone in diabetic retinopathy', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kareem Md Ali, Resident', 'role': 'CONTACT', 'email': 'kmasms2712@gmail.com', 'phone': '+201091319590'}, {'name': 'Ziad Hn El Daly, MD', 'role': 'CONTACT', 'phone': '+201091319590'}], 'overallOfficials': [{'name': 'Ziad Hn El Daly, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assuit Universoty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kareem Mohammad Ali', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Kareem Mohammad Ali', 'investigatorAffiliation': 'Assiut University'}}}}